Surgeons and other healthcare providers often wear an over garment during operating procedures in order to enhance the sterile condition in the operating room and to protect the wearer. The over garment is typically a gown that has a main body portion to which sleeves and a tie cord or other securing means are attached. The tie cord encircles the wearer at the waist to keep the gown in place. In order to prevent the spread of infection to and from the patient, the surgical gown prevents bodily fluids and other liquids present during surgical procedures from flowing through the gown.
Surgical gowns were originally made of cotton or linen, were reusable, and were sterilized prior to each use in the operating room. A disadvantage of the materials used in these types of gowns is that they tend to form lint, which is capable of becoming airborne or clinging to the clothes of the wearer, thereby providing another potential source of contamination. Additionally, costly laundering and sterilization procedures were required before reuse.
Disposable surgical gowns have largely replaced the reusable linen surgical gown and many are now made in part or entirely from fluid repellent or impervious fabrics to prevent liquid penetration or “strike through.” Various materials and designs have been used in the manufacture of surgical gowns to prevent contamination in different operating room conditions. Surgical gowns are now available in a variety of different levels of imperviousness and comfort. Such gowns can typically be secured with tie cords. However, the tie cords can be cumbersome to tie and adjust to the appropriate level of comfort for each particular user and often loosen or become untied, resulting in a gown that is not maintained securely, which can put the wearer at risk for exposure to bodily fluids and other potentially hazardous materials and liquids. In addition, while other fastening means such as hook and loop materials can be used in conjunction with or in place of tie cords, other personal protective equipment such as a bouffant can become caught in the hook and loop materials based on their placement, which can be very irritating to the wearer. Moreover, in order to ensure that no blood, bone fragments, or other biologic materials or body fluids come into contact with the wearer, the collar of many surgical garments can be tight, restrictive, and uncomfortable to the wearer.
Further, gowns made from an impervious material provide a high degree of protection, but a surgical gown constructed of this type of material is typically heavy, restrictive, expensive, and uncomfortably hot to the wearer. While efforts have been made to utilize a lighter weight material in order to provide for better breathability and help reduce the overall weight of the gown, the higher the breathability of the material, the lower the repellency of the material, where the material may not meet the minimum guidelines that have been created for the rating of the imperviousness of surgical gowns, gloves and the like.
Specifically, the Association for the Advancement of Medical Instrumentation (AAMI) has proposed a uniform classification system for gowns and drapes based on their liquid barrier performance. These procedures were adopted by the American National Standards Institute (ANSI) and were recently published as ANSIA/AAMI PB70: 2012 entitled Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, which was formally recognized by the U.S. Food and Drug Administration in October, 2004. This standard established four levels of barrier protection for surgical gowns and drapes. The requirements for the design and construction of surgical gowns are based on the anticipated location and degree of liquid contact, given the expected conditions of use of the gowns. The highest level of imperviousness is AAMI level 4, used in “critical zones” where exposure to blood or other bodily fluids is most likely and voluminous. The AAMI standards define “critical zones” as the front of the gown (chest), including the tie cord/securing means attachment area, and the sleeves and sleeve seam area up to about 2 inches (5 cm) above the elbow.
In light of the above, a need exists for a surgical garment (e.g., a surgical gown) that meets the AAMI level 4 standard while at the same time being stretchable, soft, breathable, and cool to maximize the comfort for the wearer (e.g., medical care providers). A need also exists for a fastening means that maintains such a garment securely in place during use but is arranged in manner that does not result in other personal protective equipment (e.g., a bouffant) becoming attached or caught in the fastening means. Further, a need exists for a collar that can prevent gapping at the neck opening of the surgical garment, which can put the wearer at risk of exposure to blood, bone fragments, or other biologic materials.